Welcome to our Serialization Series. Wondering how to comply with the newest drug serialization regulations on time, on budget and with perfect execution? You’re in the right place.
In this blog, Matteo Barbieri, senior R&D product manager at SEA Vision and Zenith Technologies’ serialization director, Carlos Machado talk us through some of the key challenges and opportunities.
The US and European healthcare industry is changing rapidly. Pharmaceutical serialization legislation in these markets is just around the corner, and needs to be tackled in a pragmatic and proactive way. With this in mind, this blog series will focus on addressing some of the key challenges faced by the industry in planning and implementing drug serialization.
For many years, legislation in China, South America and parts of the Middle East has driven U.S. and European pharmaceutical manufacturers to develop serialization programmes for shipment into these markets. We’ve seen it before, but new legislative frameworks in the U.S. and European markets present a new set of challenges, and many companies are scrambling to meet the requirements in time.
However, serialization doesn’t need to be panic inducing. It actually presents an exciting opportunity for the industry. Pharmaceutical serialization creates transparency. It allows us to better monitor our supply chain processes, creating more accuracy in packaging and shipment, and increasing process efficiency – all while keeping costs down.
In fact, drug serialization is the answer to some of the biggest problems facing pharmaceuticals. It links the serial numbers of products to their manufacturer, and to reimbursement systems. If done carefully and thoroughly, this will allow us to reduce numerous costly problems, including counterfeit drugs and reimbursement fraud.
In short, serialization presents a unique prospect for the pharmaceutical industry and companies that rise to the challenge will stand out against their competitors. We should work hard to seize this opportunity, and to eliminate some of the gaps down which profits, protocol and patient safety have too often slipped.
Next up in the Serialization Series, Carlos Machado and Matteo Barbieri talk us through some of the drivers of serialization, from patient safety to cost considerations.